Suboptimal Antiretroviral Drug Levels and Virologic Failures among PLHIV at a Rural Referral Hospital in South Western Uganda: A Descriptive Cross-sectional Study.

2020 ◽  
Author(s):  
Silvano Samba Twinomujuni ◽  
Patrick E. Ogwang ◽  
Felicitas Roelofsen ◽  
Jackson K. Mukonzo ◽  
Esther Cathyln Atukunda
Keyword(s):  
Clinical Trial ◽  
Steady State ◽  
Viral Load ◽  
Cd4 Count ◽  
Referral Hospital ◽  
Hiv Care ◽  
Drug Levels ◽  
Antiretroviral Drug ◽  
Persons Living With Hiv ◽  
Western Uganda

Abstract Background: Achieving favorable HIV treatment outcomes is a major challenge, particularly due to non-adherence and consequent sub-therapeutic plasma antiretroviral drug levels. This is often complicated by the development of resistant strains due to mutations. Monitoring antiretroviral drug levels in the blood of patients enrolled on ART can reveal if levels are too high, enough, or too low. High levels may lead to dose-dependent side effects and sub-therapeutic levels could promote treatment failure and resistance. In Uganda, as part of routine HIV care, plasma antiretroviral drug level is estimated indirectly by clinic-based pill counts and patient self-reported adherence, which give no evidence of ingested medication. This study aimed at exploring steady-state nevirapine and efavirenz drug levels in HIV patients accessing ART at a rural referral hospital in South Western Uganda. Methods: This study was nested into a randomized clinical trial that evaluated the effect of Artemisia annua L. and Moringa oleifera on immunological response and viral load among persons living with HIV (PLHIV). In the parent study, 250 HIV-infected patients with continued immunologic suppression (CD4 count < 350cells/µL) despite a minimum of one-year on ART were enrolled. Out of 250 clinical trial participants, 95 were randomly selected for steady-state efavirenz and nevirapine plasma concentration sampling having taken the last at bedtime. Additionally, CD4 count, HIV load, liver, and renal function tests were determined. Participants were also interviewed for adherence, and factors that affect blood drug levels.Results: Of the 95 participants sampled, 67 (71%) and 28 (30%) were on efavirenz or nevirapine based ART respectively. The median viral load for participants on the efavirenz regimen was 490 copies/mL (IQR 116, 1900) while that for the participants on the nevirapine regimen was 500 copies/mL (IQR 137, 1270). The median plasma level for the participants on the nevirapine regimen (6.56 mg/L IQR 4.50, 9.80) was higher than that for the participants on the efavirenz regiment (2.54 mg/L IQR 1.47, 5.12). The prevalence of virologic failure among participants sampled on the efavirenz regimen was higher (37%) compared to that of the participants on the nevirapine regimen (21%). 30% of all plasma samples tested had sub-therapeutic levels of either efavirenz or nevirapine, including 2% in which no drugs were detected.Conclusion: Periodic therapeutic drug monitoring should be incorporated as one of the components in the monitoring of ART adherence to ensure adequate blood levels among adults accessing ART at MRRH, SW Uganda.

scholarly journals 4180 CD4 count is a prognostic marker in persons living with HIV and non-small cell lung cancer in the Bronx

2020 ◽  
Vol 4 (s1) ◽  
pp. 24-24
Author(s):  
Madelyn Klugman ◽  
Melissa Fazzari ◽  
Mindy Ginsberg ◽  
Thomas Rohan ◽  
David Hanna ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Viral Load ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Cd4 Count ◽  
Small Cell Lung ◽  
Hiv Patients ◽  
Persons Living With Hiv ◽  
Living With Hiv

OBJECTIVES/GOALS: There is a high burden of lung cancer in persons living with HIV (PLWH). The role that HIV status, by levels of immune function and viral load, has on survival from lung cancer is not fully understood. The study’s objectives were to assess 1) the association of HIV with survival in non-small cell lung cancer (NSCLC) and 2) prognostic factors in PLWH with NSCLC. METHODS/STUDY POPULATION: Participants were from a cohort of lung cancer patients diagnosed between 2004-2017 in the Bronx, NY, with vital status ascertainment at least annually. We compared survival from NSCLC diagnosis between HIV-negative patients (HIV-, N = 2881) and PLWH (N = 88), using Cox regression, accounting for clinical and sociodemographic factors including smoking status. In three separate comparisons to HIV-, PLWH were dichotomized by CD4 count (<200 vs. ≥200 cells/μL), CD4/CD8 ratio (median, <0.43 vs. ≥0.43) and HIV viral load (VL) suppression (<75 vs. ≥75 copies/mL). In PLWH only, we assessed the relationships of CD4 count, CD4/CD8 ratio, and VL at diagnosis with survival adjusting for age, sex, and cancer stage. CD4 count and CD4/CD8 ratio were also examined as time-varying variables using a counting process approach. RESULTS/ANTICIPATED RESULTS: PLWH were younger (median 56 years, IQR 51-52 vs. 68, IQR 60-76) and more likely to be current smokers (58% vs. 37%) at diagnosis than HIV- patients. Median survival was lower in PLWH [1.1 years, 95% confidence interval (95%CI): 0.6-1.3] than in HIV- [1.6 (1.5-1.7)]. Survival comparing PLWH with higher CD4/CD8 to HIV- was similar [hazard ratio (HR), 95%CI: 0.63 (0.37-1.07)], but those with lower CD4/CD8 experienced worse survival (HR = 1.74, 95%CI: 1.07-3.89). Among PLWH, having a CD4 count < 200 cells/μL was associated with over twice the risk of death compared to those with CD4 ≥ 200 cells/μL (HR = 2.37, 95%CI: 1.14-4.92). VL and CD4/CD8 ratio were not associated with survival. Lower time-updated CD4 count was also associated with worse survival (HR = 2.19 for CD4 <200 vs. >200 cells/μL, 95%CI: 1.16-4.13). DISCUSSION/SIGNIFICANCE OF IMPACT: Among persons with NSCLC, CD4/CD8 ratio nearest diagnosis was shown to distinguish mortality risk in PLWH compared with HIV- patients. In addition, PLWH with low CD4 had worse prognosis than PLWH who had higher CD4 counts. These results suggest HIV immune status to be an essential component influencing survival in lung cancer.

scholarly journals 362. Hepatitis C Virus (HCV) Co-Infection in Women Living with Human Immunodeficiency Virus (HIV) in Northwest Louisiana

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S189-S190
Author(s):  
Ethar Mohammed ◽  
Puja Nambiar
Keyword(s):  
Risk Factors ◽  
Viral Load ◽  
Drug Use ◽  
Cd4 Count ◽  
Hiv Care ◽  
High Risk Population ◽  
Underrepresented Minority ◽  
Hcv Treatment ◽  
Women Living With Hiv ◽  
Living With Hiv

Abstract Background HIV and HCV infection are emerging global public health problems. People living with untreated HIV infection have higher HCV viral loads and more rapid HCV disease progression with twice the rates of perinatal HCV transmission. Data are lacking in HCV coinfected women living with HIV. Our study reviewed underrepresented minority group of women living with HIV/HCV in Northwestern Louisiana to better understand epidemiology, risk factors and access to care among this cohort. Methods Women with HIV/HCV coinfection aged 18–70 years who presented to an academic medical center between November 2011 and November 2018 were included for analysis. A retrospective chart review was conducted. Data were collected and analyzed on demographics (age, race), risk factors (sexual history, drug use), HIV (viral load, CD4 count, antiretroviral treatment (ART)), and HCV (viral load level and antibody, genotype, alanine transaminase, liver fibrosis, liver cirrhosis, referral, and treatment). Results A total of 41 patients met our inclusion criteria. The mean age was 52 years. Of these HIV/ HCV coinfected women, 27 (66%) were African American and 14 (34%) Caucasian. 18 (44%) had history of Injection drug use. Thirty-nine out of 41 (95%) were linked to HIV care and on antiretroviral therapy with 36 (88%) with CD4 count >200. Twenty-three out of 41 (56%) was referred for HCV treatment but only 11 (26%) co-infected patients received treatment for HCV. Conclusion In this cohort of HCV/HIV coinfected women, only 26% of the women received HCV treatment. Some of the barriers include access to providers, linkage to care and behavioral and socioeconomic factors. The lack of timely appropriate HCV care in this underserved high-risk population is alarming especially in the current era of highly effective direct-acting antiviral therapy for HCV. Despite improved HIV care, further work needs to focus on optimizing HCV screening, linkage and treatment uptake in order to overcome multiple barriers to HCV elimination in this patient population. Disclosures All authors: No reported disclosures.

scholarly journals 2494. Real-World Use of Ibalizumab in Physician Office Infusion Centers (POICs)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S865-S865 ◽  
Author(s):  
Richard C Prokesch ◽  
Claudia P Schroeder ◽  
Thomas C Hardin ◽  
Lucinda J Van Anglen
Keyword(s):  
Clinical Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Real World ◽  
Clinical Trial Data ◽  
Cd4 Count ◽  
Drug Classes ◽  
Post Marketing ◽  
Marketing Data ◽  
Hiv 1

Abstract Background Ibalizumab-uiyk (IBA) was recently approved for the treatment of multi-drug-resistant HIV-1 infection in patients (pts) failing other antiretroviral regimens. Clinical trial data demonstrated a decrease in HIV-1 viral load in 83% and 43% of patients (n = 40) receiving IBA for 2 and 25 weeks (weeks), respectively. Real-world post marketing data are needed. This pilot study reports the experience of IBA utilization in POICs. Methods Medical records of patients receiving intravenous IBA from approval through April 2019 were reviewed. Data collected include demographics, infection and treatment history, IBA regimen and adverse events. Plasma HIV-1 RNA viral load (log10 copies/mL) and CD4 count (cells/µL) were collected at baseline and as available during therapy. Based on available follow-up (FU) labs, response was assessed at 4–10 weeks (FU 1), 14–22 weeks (FU 2), and 24–37 weeks (FU 3). Results Nine patients (mean age: 48 ± 11 years, 67% male) from 7 POICs received IBA for a median duration of 33 weeks (range 4–43). Median length of HIV-1 diagnosis was 22 years (range 8–25). Resistance to ≥1 drug in at least 3 drug classes was reported in 56%. All patients received at least one concurrent anti-retroviral agent. IBA was initiated at 2000 mg followed by 800 mg every 2 weeks. All patients received infusions as scheduled (151 total infusions) except for one requiring a second loading dose. Baseline mean CD4 count and viral load were 49 cells/µL and 4.9 log10 copies/mL, respectively. Labs obtained at FU 1 indicated a decrease in viral load of at least 0.5 log10 copies/mL in 6/8 patients (75%); a mean reduction of 2.1 ± 1.8 log10 copies/mL (Table 1). Mean HIV-1 titers available for patients at FU 2 (n = 6) and FU 3 (n = 7) were 3.1 ± 2.0 and 3.2 ± 2.6 log10 copies/mL, respectively. Mean CD4 counts were 65 ± 57 cells/µL at FU 1, 96 ± 61 cells/µL at FU 2 and 88 ± 82 cells/µL at FU 3. Adverse events were reported in 8 patients (89%), most common itching/rash, diarrhea and abdominal pain. None resulted in discontinuation of IBA. Conclusion This study confirms the antiviral activity of IBA in patients with advanced HIV-1 infection in the real-world setting. We observed well-tolerated therapy with an early reduction in HIV-1 viral load of 75%, followed by a 43% reduction ≥24 weeks, consistent with the clinical trial. Disclosures All authors: No reported disclosures.

scholarly journals Cell-Mediated Immune Predictors of Vaccine Effect on Viral Load and CD4 Count in a Phase 2 Therapeutic HIV-1 Vaccine Clinical Trial

EBioMedicine ◽  
2017 ◽  
Vol 24 ◽  
pp. 195-204 ◽  
Author(s):  
Yunda Huang ◽  
Giuseppe Pantaleo ◽  
Gonzalo Tapia ◽  
Brittany Sanchez ◽  
Lily Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Viral Load ◽  
Cd4 Count ◽  
Phase 2 ◽  
Vaccine Clinical Trial ◽  
Hiv 1 ◽  
Vaccine Effect

scholarly journals Characteristics and treatment outcomes of HIV infected elderly patients enrolled in Kisii Teaching and Referral Hospital, Kenya

2020 ◽  
Vol 20 (4) ◽  
pp. 1537-45
Author(s):  
Benuel Nyagaka ◽  
Stanslaus Kiilu Musyoki ◽  
Lucy Karani ◽  
Anthony Kebira Nyamache
Keyword(s):  
Viral Load ◽  
Elderly Patients ◽  
Clinical Care ◽  
Cd4 Count ◽  
Referral Hospital ◽  
People Living With Hiv ◽  
Keywords Hiv ◽  
Significant Difference ◽  
Baseline Characteristics ◽  
Hiv Aids

Background: A better understanding of the baseline characteristics of elderly people living with HIV/AIDS (PLWHA) is relevant because the world’s HIV population is ageing. Objectives: This study aimed to evaluate the baseline characteristics of PLWHA aged ≥ 50years at recruitment to HIV/ AIDS clinic compared against the viral load (VL) and CD4 count among patients attending Kisii Teaching and Referral Hospital (KTRH), Kenya. Methods: We retrospectively evaluated temporal inclinations of CD4 levels, viral load change and baseline demographic characteristics in the electronic records at the hospital using a mixed error-component model for 1329 PLWHA attending clinic between January 2008 and December 2019. Results: Findings showed a significant difference in the comparison between baseline VL and WHO AIDS staging (p=0.026). Overall VL levels decreased over the period significantly by WHO AIDS staging (p<0.0001). Significant difference was ob- served by gender (p<0.0001), across age groups (p<0.0001) and baseline CD4 counts (p=0.003). There were significant differences in WHO staging by CD4 count >200cell/mm3 (p=0.048) and residence (p=0.001). Conclusion: Age, WHO AIDS staging, gender and residence are relevant parameters associated with viral load decline and CD4 count in elderly PLWHA. A noticeable VL suppression was attained confirming possible attainment of VL suppression among PLWHA under clinical care. Keywords: HIV infected elderly patients; Kisii Teaching and Referral Hospital, Kenya.

scholarly journals 1769. Viral Suppression Among Participants of the Patient-Centered HIV Care Model Project—A Collaboration Between Community-Based Pharmacists and HIV Clinical Providers

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S65-S65
Author(s):  
Kathy Byrd ◽  
John Hou ◽  
Patrick Clay ◽  
Tim Bush ◽  
Ambrose Delpino ◽  
...  
Keyword(s):  
Viral Load ◽  
Viral Suppression ◽  
Community Pharmacists ◽  
Hiv Care ◽  
Care Model ◽  
Patient Centered ◽  
Community Based ◽  
Medication Therapy ◽  
Persons Living With Hiv ◽  
Measurement Period

Abstract Background The patient-centered HIV care model was developed to integrate community pharmacists with HIV clinical providers to deliver patient-centered HIV care. The project required 10 clinics to share, with their partnered community-based pharmacists, patients’ medical histories, laboratory results, and medications. Pharmacists reviewed the clinic data and worked directly with participants and/or their partnered clinics to make recommendations and discuss potential intervention strategies for identified therapy-related problems. Methods We calculated the proportion of persons virally suppressed (&lt;200 copies/mL at the last test in each of two 12-month measurement periods), pre- and post-model implementation. Included in the analysis were persons with ≥1 HIV viral load in each measurement period. McNemar’s test was used to compare the proportion virally suppressed, pre- and postimplementation. Multivariable logistic regression was used to determine factors associated with viral suppression, postimplementation. Participant demographics and the proportion of days covered (PDC; a measure used to calculate adherence to medication therapy) were used as explanatory variables in the model. The PDC was modified to account for the time to the last viral load in the measurement period, and was stratified into 4 categories: ≥90%, &lt;90–80%, &lt;80–50%, and &lt;50%. Results With 765 persons enrolled, the plurality of those included in the analysis (n = 648) were non-Hispanic black (n = 286), male (n = 470), and had a median age of 49 years (IQR=38–56). Viral suppression improved 16.3% from 73.9% to 85.9%, pre- to postimplementation (P &lt; 0.001). Persons who had higher modified PDC (OR 1.9 per category level; 95% CI 1.4–2.6), were currently employed (OR 4.1; 1.6–12.8), or age &gt;50 years (OR 4.7; 2.1–11.8), had greater odds of being suppressed. Non-Hispanic black persons were less likely to be suppressed (OR 0.2; 0.1–0.6); however, viral suppression among this group improved from 62.5% to 77.6%, pre- to postimplementation (P &lt; 0.001). Conclusion Collaborations between community pharmacists and HIV clinic providers that seek to identify and address HIV therapy-related problems can lead to improved viral suppression among persons living with HIV. Disclosures P. Clay, Jaguar Health, Inc.: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. Merck & Co., Inc.: Investigator, Research grant. A. Delpino, Walgreens: Employee and Shareholder, Salary.

The effect of highly active antiretroviral treatment on viral load and antiretroviral drug levels in breast milk

AIDS ◽  
2005 ◽  
Vol 19 (16) ◽  
pp. 1912-1915 ◽  
Author(s):  
Robert Colebunders ◽  
Beata Hodossy ◽  
David Burger ◽  
Tania Daems ◽  
Kristien Roelens ◽  
...  
Keyword(s):  
Viral Load ◽  
Breast Milk ◽  
Antiretroviral Treatment ◽  
Drug Levels ◽  
Highly Active ◽  
Highly Active Antiretroviral Treatment ◽  
Antiretroviral Drug

Feasibility and Acceptability of iThemba: A mobile health application to support engagement in HIV care and viral load suppression: A pilot study (Preprint)

2020 ◽  
Author(s):  
Samanta Lalla-Edward ◽  
Nkuli Mashabane ◽  
Lynsey Steward-Isherwood ◽  
Lesley Scott ◽  
Kyle Fyvie ◽  
...  
Keyword(s):  
Viral Load ◽  
Mobile Health ◽  
Technical Assistance ◽  
Hiv Treatment ◽  
Hiv Care ◽  
Mobile Health Application ◽  
Persons Living With Hiv ◽  
Turn Around Time ◽  
Health Application ◽  
To Receive

BACKGROUND South Africa has the highest burden of HIV and the largest HIV treatment programme in the world. However, retention in care and medication adherence remains problematic and innovative solutions for improving HIV care are needed. The increasing availability and use of mobile technology can support positive clinical outcomes for persons living with HIV (PLWH). iThemba is a mobile health application (app), designed with input from South African health professionals and patients, promoting engagement with HIV care through access to medical results. OBJECTIVE The feasibility and acceptability of receiving HIV viral load (VL) results through the app was evaluated. METHODS Using purposive sampling, adults having routine VL phlebotomy were recruited from two Johannesburg health facilities. After signed consent, the app was downloaded to their Android smartphones, phlebotomy performed, and sample barcode scanned through their phone to link the sample and app. Participants received notification of result availability and logged into the app. Results were presented with an explanation and recommended action. RESULTS 750 people were screened to enrol 500 participants. 15·0% (113/750) failed eligibility screening. 21·0% (137/637) had smartphone technical limitations preventing enrolment. Results were released to 92·0% (461/500) of participant’s phones, with app technical issues and laboratory operational issues limiting the number of released results. 360/461 (78·0%) results were viewed in app, with a median time from notification of availability to result viewed being 15·5 hours. Turn-around-time from phlebotomy to result received was 6 days for users vs 56 days with standard-of-care (SOC). 20 users received unsuppressed results (VL>1000copies/mL). Turn-around-time for unsuppressed results was 7days for users vs 37·5days with SOC. 12 users returned for a confirmatory VL within the study period. 262/500(52·4%) users completed an exit survey where 23·2% (58/250) reported challenges viewing their VL result. 58·3% (35/60) reported they overcame challenges with technical assistance from others. 97·3% (255/262) wanted to continue using app to receive VL results. CONCLUSIONS Using iThemba Life to receive VL results was well received by users despite limited smartphone access for some participants. App users received results 10 times sooner than SOC, and five times sooner than SOC if their VL>1000cp/mL. This increased notification speed led to participants wanting to continue iThemba Life usage.

CSF antiretroviral drug penetrance and the treatment of HIV-associated psychomotor slowing

Neurology ◽  
2001 ◽  
Vol 57 (3) ◽  
pp. 542-544 ◽  
Author(s):  
N. Sacktor ◽  
P. M. Tarwater ◽  
R. L. Skolasky ◽  
J. C. McArthur ◽  
O. A. Selnes ◽  
...  
Keyword(s):  
Viral Load ◽  
Highly Active Antiretroviral Therapy ◽  
Neuropsychological Tests ◽  
Plasma Viral Load ◽  
Cd4 Count ◽  
Psychomotor Speed ◽  
Psychomotor Slowing ◽  
Highly Active ◽  
Antiretroviral Drug ◽  
The Mean

The authors evaluated whether highly active antiretroviral therapy (HAART) with multiple CSF-penetrating drugs results in greater improvement in HIV-associated psychomotor slowing than HAART with a single CSF-penetrating drug. Both groups had improvement in CD4 count, plasma viral load, as well as two tests of psychomotor speed. Comparing the two groups, there were no differences in the mean change for CD4 count, viral load, or any of the neuropsychological tests. Multiple and single CSF-penetrating HAART may be equivalent for treating HIV-associated psychomotor slowing.

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